Trials / Completed
CompletedNCT03251079
PRECISION Study: Multi-center Study of Performance of a Novel Implanted CGM System Using a Next Generation Transmitter and Algorithm
PRECISION Study: A Prospective, Multi-center Evaluation of Precision, Compression and Performance of a Novel Implanted Continuous Glucose Sensor Using a Next Generation Transmitter and Algorithm
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Senseonics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this multi-center, prospective clinical study is to evaluate the performance of a novel, implanted Senseonics continuous glucose monitoring system (Senseonics CGM System) compared to Yellow Springs Instrument (YSI) glucose analyzer reference standard measurements using a next generation transmitter and algorithm. Other measures evaluated will be the effects of compression on performance and the safety of the Senseonics CGM system.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Continuous glucose monitoring system | Implanted continuous glucose monitoring system |
Timeline
- Start date
- 2017-07-25
- Primary completion
- 2018-02-01
- Completion
- 2018-02-01
- First posted
- 2017-08-16
- Last updated
- 2024-02-12
- Results posted
- 2024-02-12
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03251079. Inclusion in this directory is not an endorsement.